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ClinicalTrials.gov Identifier: NCT00949065

Recruitment Status
: Unknown

Verified July 2009 by University of Giessen. Recruitment status was: Not yet recruiting

The purpose of this study is to determine whether intravenous immunoglobulins are effective in the treatment of complex-regional pain syndrome.

Condition or disease

Intervention/treatment

Phase

Complex Regional Pain Syndrome Type 1

Biological: intravenous immunoglobulins

Phase 3

Detailed Description:

CRPS, a chronic pain syndrome associated with trophic disturbances is a frequent complication after limb trauma. More than one third of the CRPS will continue to chronic disease including loss of function in one limb. Some reports implicate an autoimmune pathogenesis of CRPS. Especially the finding of autoantibodies against peripheral neurons and successful treatment in single cases provide evidence for a possible successful treatment of CRPS with intravenous immunoglobulins (IvIg). Therefore IvIg may be an important anti-inflammatory treatment to prevent severe chronification of CRPS. Since IvIg is mainly effective in B-cell-mediated autoimmune diseases, autoantibodies against autonomic neurons and the concentration of B-cell activating factors BAFF and APRIL will be measured in the course of the study.

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Ages Eligible for Study:

18 Years to 80 Years (Adult, Senior)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

CRPS 1 (according to the IASP criteria) between 6 weeks and 6 months after diagnosis

skin temperature of the affected side equal or higher than on non-affected side

no change of the analgetic or co-analgetic medication within the last 10 days

Exclusion Criteria:

Immunosuppressive or immunomodulatory treatment within the last three months